The following data is part of a premarket notification filed by Dentsply International, Inc. with the FDA for Mtm(r) Clear Aligner.
| Device ID | K132145 |
| 510k Number | K132145 |
| Device Name: | MTM(R) CLEAR ALIGNER |
| Classification | Aligner, Sequential |
| Applicant | DENTSPLY INTERNATIONAL, INC. SUSQUEHANNA COMMERCE CTR., 221 W. PHILADELPHIA ST., SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL, INC. SUSQUEHANNA COMMERCE CTR., 221 W. PHILADELPHIA ST., SUITE 60 York, PA 17404 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-11 |
| Decision Date | 2013-10-11 |
| Summary: | summary |